Gastrointestinal tissue approximation clip (gi tac) system

ABSTRACT

A gastrointestinal tissue approximation clip (“GI TAC”) system for approximating tissue defects, the GI TAC system including an applicator that is sized to travel through an instrument channel of an endoscope; a plurality of tissue approximation clips that are transported to a plurality of locations about a tissue defect by the applicator; a suture coupled to at least one of the tissue approximation clips; and a clip approximation means for approximating the tissue approximation clips. The clip approximation means and the tissue approximation clips are sized respectively to travel through the instrument channel, and the tissue approximation clips are adapted to be detachably coupled to the applicator.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of and claims priority toU.S. patent application Ser. No. 17/148,455 that was filed on Jan. 13,2021, which claims priority to U.S. provisional patent application No.62/960,619 that was filed on Jan. 13, 2020, the disclosures of which areincorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to gastrointestinal tissue approximationclip system, and more particularly, a gastrointestinal tissueapproximation clip system and a method for closing large defects asfound in certain indications in gastroenterology.

The field of gastroenterology is expanding rapidly due to the practicebroadening its scope. One of the areas in gastroenterology that has beenrapidly developing is endoscopic resection of different gastrointestinal(GI) abnormalities including (but not limited to) polyps, early cancer,and other lesions (abnormal growths) associated with GI indications.

A few different resection techniques have been developed so far, whichinclude (but are not limited to) endoscopy mucosal resection (EMR),endoscopic submucosal dissection (ESD), endoscopic full-thicknessresection (EFTR), and submucosal tunneling endoscopic resection (STER).However, the above techniques may be fraught with a few complications.Two of the most common are bleeding and perforation of the tissue. Foreither complication, a well-trained gastroenterologist would initiallyattempt a closure of the defect with endoscopic clip(s) (essentiallybringing tissue edges in close apposition that is akin to suturing), orclipping of the blood vessel(s). There are also combined GI-surgeryprocedures such as Natural Orifice Transluminal Endoscopic Surgery(NOTES) where an opening on the gastrointestinal wall is intentionallycreated to go beyond the GI tract and perform surgery on structures suchas the gallbladder. The opening itself has to be closed off at the endof this procedure.

However, there are several drawbacks to the endoscopic clips and devicesknown in the art, some of which will be discussed although they do notrepresent an exhaustive list of all of the clips and devices known inthe art. Traditional endoscopic clips 10, as shown in FIG. 1, are ratherlimited in their application with regards to closing largeperforations/defects because approximating the edges of such largedefects can be extremely difficult, if not impossible, due to thelimitation of the small diameters of their jaws (as shown in the jaw 15of FIG. 1). Other clips were devised to close such large defects; onesuch clip is a larger variation that is attached on tip of theendoscope, i.e. over-the-scope clip. However, due to the large size ofthese clips, the gastroenterologist would have to take the endoscope outof the patient and spend time to place the larger clip on the tip of theendoscope and then re-introduce the endoscope with the larger clipattached thereon back into the patient. Such large clips traditionallyrequired a therapeutic endoscope that is thicker in diameter to otherendoscopes to accommodate the larger clip size. Furthermore, a deviceplaced over the endoscope can increase the bulk of the endoscope whenre-introducing the endoscope and the clip into the patient thus makingthe procedure more difficult, time consuming, and potentially risky. Inaddition, use of a shorter endoscope, referred to as either an “upperendoscope” or “gastroscope,” is required for these large clips; this islimiting due to the upper endoscope's shorter length than traditionalendoscopes, which in turn means that the upper endoscope can beintroduced into the patient only to a certain distance resulting in somelocations, e.g. proximal colon, likely being outside of its range.

Another device has been developed to emulate surgical suturing to closea defect tightly. However, the gastroenterologist would still berequired to take the endoscope out of the patient to place this suturingdevice on the tip of the endoscope and re-introduce into the patient theendoscope with the suturing device attached thereon. Additionally, thissuturing device requires a therapeutic endoscope with all of itsattendant drawbacks as described above along with the upper endoscope.Thus, this suturing device requires placement over the endoscope, whichin turn increases the bulk of the endoscope when re-introducing theendoscope and the suturing device into the patient for closure of thedefect. The therapeutic endoscope for the suturing device only comes ina shorter scope length, which further limits the distance that thisdevice can reach, meaning locations such as the proximal colon and muchof the small intestine are likely to be inaccessible with the suturingdevice. Additionally, this device operates quite differently fromtraditional clips or large clips. Thus, the usage of this devicerequires training sessions, repeat training session(s) if not used oftenand the gastroenterologist needs to be reminded of how the suturingdevice operates, and more effort overall than other devices.

Alternatives to the above listed devices include emergent surgery,interventional radiology (IR) procedure for uncontrollable bleeding,observation with antibiotics and nil per os (NPO) status to see if thedefect would close on its own. However, these procedures are eitherhighly invasive or require longer observation periods, and thus, longerand costlier hospital stays. If these devices fail, much time will berequired before alternatives such as surgery can be performed; thus,there will be increased risk for the patient, including death, throughevolution into a clinical scenario such as pneumoperitonuem,pneumothorax, tension pneumothorax, etc.

Accordingly, in view of the problems described above, there exists aneed for a tissue approximation system that allows the physician toclose large GI defects quickly and efficiently, provides cost-savings,decrease complications for the patient, and would require little to noadditional training. This invention is directed to solve these problemsand satisfy a long-felt need.

SUMMARY OF THE INVENTION

The present invention contrives to solve the disadvantages of the priorart. The present invention is directed to a tissue approximation clipsystem.

An object of the present invention is to provide a gastrointestinaltissue approximation clip (“GI TAC”) system for approximating tissuedefects, the GI TAC system comprising: an applicator that is sized totravel through an instrument channel of an endoscope; first and secondtissue approximation clips that are transported to first and secondlocations of a tissue defect respectively by the applicator toapproximate the tissue defect; first and second sutures attached to thefirst and second tissue approximation clips respectively; and a clipapproximation means for approximating the first and second tissueapproximation clips. The clip approximation means is sized to travelthrough the instrument channel, the first and second tissueapproximation clips are sized to travel through the instrument channel,and the first and second tissue approximation clips are adapted to bedetachably coupled to the applicator.

Another object of the present invention is to provide a GI TAC systemfor approximating tissue defects, the GI TAC system comprising: anapplicator that is sized to travel through an instrument channel of anendoscope; first and second tissue approximation clips that aretransported to the first and second locations of a tissue defectrespectively by the applicator to approximate the tissue defect; andfirst and second sutures attached to the first and second tissueapproximation clips respectively. The first and second tissueapproximation clips are sized to travel through the instrument channel,and the first and second tissue approximation clips are adapted to bedetachably coupled to the applicator.

Yet another object of the present invention is to provide a method forapproximating a tissue defect using a GI TAC system, the methodcomprising the steps of: positioning a distal end of an insertion tubeof an endoscope towards a tissue defect inside of a patient; directing,via an applicator, a first tissue approximation clip, detachablyattached to the applicator, through an instrument channel of theendoscope and towards the tissue defect; placing the first tissueapproximation clip on a first location of the tissue defect and clampingthe first tissue approximation clip thereon; detaching the applicatorfrom the first tissue approximation clip and withdrawing the applicatorfrom the instrument channel of the endoscope; directing, via theapplicator, a second tissue approximation clip, detachably attached tothe applicator, through the instrument channel of the endoscope andtowards the tissue defect; placing the second tissue approximation clipon a second location of the tissue defect and clamping the second tissueapproximation clip thereon; and detaching the applicator from the secondtissue approximation clip and withdrawing the applicator from theinstrument channel of the endoscope. First and second sutures areattached to the first and second tissue approximation clipsrespectively. Furthermore, each of the first and second tissueapproximation clips includes: a body portion; and a grasping portioncoupled to the body portion. The body portion is detachably coupled tothe applicator. The grasping portion includes a movable jaw that isconstructed to move from a spaced-apart position to an approximatedposition, or move from the approximated position to the spaced-apartposition. The grasping portion is configured to grasp onto tissue duringthe placing steps.

Yet another object of the present invention is to provide agastrointestinal tissue approximation clip (“GI TAC”) system forapproximating tissue defects, the GI TAC system including an applicatorthat is sized to travel through an instrument channel of an endoscope; aplurality of tissue approximation clips that are transported to aplurality of locations about a tissue defect by the applicator; a suturecoupled to at least one of the tissue approximation clips; and a clipapproximation means for approximating the tissue approximation clips.The clip approximation means and the tissue approximation clips aresized respectively to travel through the instrument channel.Additionally, the tissue approximation clips are adapted to bedetachably coupled to the applicator.

Yet another object of the present invention is to provide A method forapproximating a tissue defect using a gastrointestinal tissueapproximation clip (“GI TAC”) system, the method including the steps of:positioning a distal end of an insertion tube of an endoscope towards atissue defect inside of a patient; directing, via an applicator throughan instrument channel of the endoscope and towards the tissue defect, afirst tissue approximation clip of a plurality of tissue approximationclips, the first tissue approximation clip detachably attached to theapplicator and coupled to a suture; placing the first tissueapproximation clip on a first location about the tissue defect andclamping the first tissue approximation clip thereon; detaching theapplicator from the first tissue approximation clip and withdrawing theapplicator from the instrument channel of the endoscope; threading thesuture through a pass-through hole of a second tissue approximation clipof the plurality of tissue approximation clips; directing, via theapplicator, the second tissue approximation clip, detachably attached tothe applicator, through the instrument channel of the endoscope andtowards the tissue defect; placing the second tissue approximation clipon a second location about the tissue defect and clamping the secondtissue approximation clip thereon; and detaching the applicator from thesecond tissue approximation clip and withdrawing the applicator from theinstrument channel of the endoscope.

The advantages of the present invention are: (1) the endoscopist doesnot need to take the endoscope out of the patient to use the GI TACsystem; (2) endoscopists and their assistants are familiar with usingclips, thus the GI TAC system will be easy to use and quick to learn;(3) the clips are sized to fit through an instrument channel of anendoscope, thus removing the need for removal of the endoscope from thepatient, fitting a device or clip over the distal end of the endoscope,and then re-introducing the endoscope, and its distal end, back into thepatient; (4) jaw portions of the tissue approximation clips that areconstructed to provide additional hold onto the tissue; (5) time savingsfrom not having to withdraw the endoscope out of the patient to use thisinvention, thus decreasing the risk of patient morbidity and mortality;(6) the GI TAC system and method can be deployed using scopes already inthe market and operating rooms thus saving costs; (7) the GI TAC systemand method can ensure precision equivalent to surgical staples that arestill employed by practitioners/physicians; and (8) the simplicity andflexibility of the GI TAC system and method in their application and thestrength that the GI TAC system and method provides in approximating andholding tissues together.

Although the present invention is briefly summarized, the fullerunderstanding of the invention can be obtained by the followingdrawings, detailed description and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentinvention will become better understood with reference to theaccompanying drawings, wherein:

FIG. 1 shows a traditional endoscopic clip;

FIGS. 2A-B show tissue approximation clips according to embodiments ofthe present invention;

FIGS. 3A-D show tissue approximation clips according to embodiments ofthe present invention with FIGS. 3A-B showing the formation of a tissueapproximation clip complex;

FIGS. 4A-L show a method for closure of a defect using a tissueapproximation clip system according embodiments of the presentinvention;

FIG. 5 shows a device for final deployment of the tissue approximationcomplex according to embodiments of the present invention;

FIGS. 6A-E show an alternative device for final deployment of the tissueapproximation complex according to embodiments of the present invention;

FIGS. 7A-E shows an alternative device for final deployment of thetissue approximation complex according to embodiments of the presentinvention;

FIG. 8 shows a cutting device according to embodiments of the presentinvention;

FIGS. 9A-C show a device for use with the tissue approximation clipsystem according to embodiments of the present invention;

FIGS. 10A-C show various views of tissue approximation clips accordingto embodiments of the present invention;

FIGS. 11A-C show a tissue approximation clip according to embodiments ofthe present invention;

FIGS. 12A-B show a tissue approximation clip according to embodiments ofthe present invention;

FIGS. 13A-D show tissue approximation clips according to embodiments ofthe present invention; and

FIGS. 14A-J show a method for closure of a defect using the tissueapproximation clip system according to embodiments of the presentinvention.

DETAILED DESCRIPTION EMBODIMENTS OF THE INVENTION

Reference will now be made in detail to the preferred embodiments of thepresent invention, examples of which are illustrated in the accompanyingdrawings, which form a part of this disclosure. It is to be understoodthat this invention is not limited to the specific devices, methods,conditions or parameters described and/or shown herein, and that theterminology used herein is for the purpose of describing particularembodiments by way of example only and is not intended to be limiting ofthe claimed invention.

Also, as used in the specification including the appended claims, thesingular forms “a”, “an”, and “the” include the plural, and reference toa particular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about”, it willbe understood that the particular value forms another embodiment.

Also, as used in the specification including the appended claims, “firstand second sutures” may denote two individual suture strands, or firstand second ends of a single suture strand.

FIG. 2A shows a tissue approximation clip 100 for approximating tissuedefects 20. The tissue approximation clip 100 includes a body portion110 and a grasping portion 120 coupled to the body portion 110, whereinthe grasping portion 120 includes a jaw having a first and second jawportions 1201, 1202. The jaw of the grasping portion 120 is preferablyof a rat-tooth type configuration as shown in FIG. 2A. The first andsecond jaw portions 1201, 1202 are constructed to move from aspaced-apart position to an approximated position, or move from theapproximated position to the spaced-apart position. In the approximatedposition, the first and second jaw portions 1201, 1202 may be fullyclosed against each other or closed upon a portion of a tissue of apatient. Other designs and configurations with respect to the jawportions 1201, 1202 of the grasping portion 120 may be considered thatdo not depart from the spirit and scope of the invention so long as thejaw is constructed to open and close whereupon closure of the jaw ontotissue provides sufficient clamping and hold onto the tissue.

The body portion 110 is detachably coupled to an applicator 400.Furthermore, the body portion 110 may be substantially cubic,substantially prismatic, substantially rectangular prism, substantiallycircular spherical, substantially oblate spheroidal, substantiallyprolate spheroidal, substantially columnar, or substantiallycylindrical. Preferably, the body portion 110 is substantially cubic,substantially rectangular prism, or substantially prismatic. For thebody portion 110 that is substantially spherical, substantially oblatespheroidal, substantially prolate spheroidal, substantially columnar, orsubstantially cylindrical, at least one surface of the body portion 110is preferably substantially flat for ease of pairing one tissueapproximation clip 101 with another tissue approximation clip 102.Overall, the tissue approximation clip 100 may be shorter and smallerthan traditional clips 10 to permit the applicator 400 to bring the pairof tissue approximation clips 101, 102 to be closer to each other,minimizing the gap between the two approximation clips 101, 102, andthus, create a tighter closure of the tissue defect 20 itself.

As shown in FIG. 2B, to further aid in the pairing of two tissueapproximation clips 101, 102, the body portion 110 of a first tissueapproximation clip 101 may be magnetic and the body portion 110 of asecond tissue approximation clip 102 may be ferromagnetic, or viceversa. Alternatively, the grasping portion 120 of the first tissueapproximation clip 101 may be magnetic and the grasping portion 120 ofthe second tissue approximation clip 102 may be ferromagnetic, or viceversa. Preferably, the body portions 110 of the first and second tissueapproximation clips 101, 102 are magnetic and ferromagneticrespectively, or vice versa.

Additionally, the body portions 110 of the first and second tissueapproximation clips 101, 102 may include joining means 130 as shown inFIGS. 3C-D. The joining means 130 are complimentary structures thatallow the tissue approximation clips 101, 102 to collapse tightly ontoeach other upon magnetic attraction when they are brought closetogether. For example, as shown in FIG. 3C, the joining means 130 of thefirst tissue approximation clip 101 may be at least one substantiallysemi-spherical projection and the joining means 130 of the second tissueapproximation clip 102 may be at least one groove constructed to receivethe semi-spherical projection of the first tissue approximation clip101, or vice versa. Alternatively, as shown in FIG. 3D, the joiningmeans 130 of the first tissue approximation clip 101 may be one or moreprojecting ridges and the joining means 130 of the second tissueapproximation clip 102 may be one or more grooves constructed to receiveany of the projecting ridges of the first tissue approximation clip 101,or vice versa with the joining means 130 of the first tissueapproximation clip 101 being one or more grooves and the joining means130 of the second tissue approximation clip 102 being one or moreprojecting ridges. Alternatively, the joining means 130 of the firsttissue approximation clip 101 may be at least one substantiallyprismatic projection and the joining means 130 of the second tissueapproximation clip 102 (complimentary to the joining means 130 of thefirst tissue approximation clip 101) may be at least one grooveconstructed to receive therein the substantially prismatic projection ofthe first tissue approximation clip 101, or vice versa. Overall, thejoining means 130 of one tissue approximation clip 101 may be a raisedprojection of any shape and number that is complimentarily received inthe joining means 130 of the other tissue approximation clip 102.Furthermore, at least one face of the body portion 110 of a first tissueapproximation clip 101 may feature a joining means 130 and at least oneface of the body portion 110 of a second tissue approximation clip 102may feature a joining means 130 that is complimentary to the joiningmeans 130 of the first tissue approximation clip 101.

Overall, the tissue approximation clip 101 is shorter than traditionalclips 10 in order to transport the tissue approximation clips 101, 102to the hole/defect itself for a tighter closure. Additionally, the bodyportions 110 of the first and second tissue approximation clips 101, 102of the tissue approximation clip system 100 may include the joiningmeans 130 as described above. Other designs and configurations withrespect to the jaw of the grasping portion 120 may be considered that donot depart from the spirit and scope of the invention so long as the jawis constructed to open in a spaced-apart position (of varying degrees)and close in an approximated position whereupon closure of the jaw ontoany position about the tissue defect 20 provides sufficient clamping tohold onto the clamped position of the tissue defect 20.

As shown in FIGS. 3A-B, a suture 201 is attached to the tissueapproximation clip 101. The suture 201 can be made from any materials,or combination thereof, known in the art, which includes syntheticabsorbables (e.g. polyglycolic acid, polylactic acid, Monocryl, andpolydioxanone) and synthetic non-absorbables (nylon, polyester, PVDF andpolypropylene). The suture 201 aids in the pairing of the tissueapproximation clips 101 where tension (e.g. from a pull) is applied tothe sutures 201, 202 (after the respective first and second tissueapproximation clips 101, 102 are clamped to first and second positionsof the tissue defect 20 respectively), which brings the clamped firstand second tissue approximation clips 101, 102 closer together such thatthey eventually pair together (through magnetic attraction and/or othermeans) as shown in FIGS. 2B and 3A-B to form a tissue approximationcomplex 150. The suture 201 may be attached to the grasping portion 120of the tissue approximation clip 101. Alternatively, the suture 201 isattached to the body portion 110 of the tissue approximation clip 101.Preferably, the suture 201 is attached to an area or a junction betweenthe body portion 110 and the grasping portion 120 of the tissueapproximation clip as shown in FIGS. 3A-B. Additionally, the bodyportion 110 also detachably couples to an applicator 400 as discussedbelow.

As shown in FIGS. 4A-L, a tissue approximation clip system 100 isprovided. As shown, the tissue approximation clip system 100 includes anapplicator 400 that is sized to travel through an instrument channel 310of an endoscope 300; first and second tissue approximation clips 101,102 that are transported to first and second locations of a tissuedefect 20 respectively by the applicator 400 to approximate the tissuedefect; first and second sutures 201, 202 attached to the first andsecond tissue approximation clips 101, 102 respectively; and a clipapproximation means for approximating the first and second tissueapproximation clips 101, 102. The clip approximation means is sized totravel through the instrument channel 310. The first and second tissueapproximation clips 101, 102 are sized to travel through the instrumentchannel 310, and are adapted to be detachably coupled to the applicator400.

The endoscope 300 is introduced into the patient through an opening ofthe patient or an opening provided by an incision. As shown in FIG. 4A,the distal end of an insertion tube 320 of the endoscope 300 (i.e. thedistal end of the endoscope 300) is directed towards the tissue defect20. The tissue defect 20 shown in FIG. 4A and in other figures (here, atear in the body wall of the stomach of a patient) is for illustrativepurposes only. The tissue approximation system 100 can be used at anylocation that is accessible by the endoscope 300. As shown in FIGS.4B-D, the applicator 400 transports the first and second tissueapproximation clips 101, 102 (described above) individually andsequentially to first and second locations of the tissue defect 20respectively. Also shown is how each of the first and second tissueapproximation clips 101, 102 has a suture attached to thereon asdescribed above. Specifically, the first suture 201 is attached to thefirst tissue approximation clip 101 as shown in FIGS. 4C and 4D prior toentry thereof into and transport through the instrument channel 310 ofthe endoscope 300, likewise for the second suture 202 and the secondtissue approximation clip 102. The first suture 201 includes a proximalend and a distal end wherein the distal end of the first suture 201attaches to the first tissue approximation clip 101 to be inserted intothe instrumental channel 310 of the endoscope 300 and directed towardsthe first position of the tissue defect 20 via the applicator 400.Furthermore, the second suture 202 includes a proximal end and a distalend wherein the distal end of the second suture 202 attaches to thesecond tissue approximation clip 201 to be inserted into theinstrumental channel 310 of the endoscope 300 and directed towards thesecond position of the tissue defect 20. Alternatively, the first andsecond sutures 201, 202 may denote opposite ends of a single suture.

The clip approximation means may be a catheter device 501 as shown inFIGS. 4E and 5, a catheter device 502 as shown in FIGS. 6A-E, or asuture adjoining clamp 601 as shown in FIGS. 7A-D. The catheter device501 as shown in FIGS. 4E and 5 is disposed at distal end of its ownapplicator, the distal end of the applicator directed towards the tissuedefect 20. As shown, the catheter device 501 includes a slidable blade520 and a through-hole 510. The slidable blade 520 may be installedwithin the catheter device 501 and positioned about the through-hole 510with the practitioner/physician controlling the slidable blade 520 ofthe catheter device 501. The through-hole 510 of the catheter device 501permits the first and second sutures 201, 202 to pass therethrough, andthe slidable blade 520 is to cut the first and second sutures 201, 202from the first and second tissue approximation clips 101, 102respectively.

When approaching the first and second tissue approximation clips 101,102, the catheter device 501 tensions the first and second sutures 201,202 such that they are brought closer together. By bringing the sutures201, 202 closer together when the first and second sutures 201, 202 aretensioned and/or pulled, the first tissue approximation clip 101approaches the second tissue approximation clip 201 and both of thetissue approximation clips 101, 201 substantially and magneticallycouples to each other into a tissue approximation complex 150 as shownin the sequence depicted in FIG. 5.

Alternatively, as shown in FIGS. 6A-E, the clip approximation means maybe a catheter device 502 which includes a slidable blade 520 and athrough-hole 510. The slidable blade 520 may be installed within thecatheter device 502 and positioned about the through-hole 510 with thepractitioner/physician controlling the slidable blade 520 of thecatheter device 502. The through-hole 510 of the catheter device 502permits the first and second sutures 201, 202 to pass therethrough, andthe slidable blade 520 is to cut the first and second sutures 201, 202from the first and second tissue approximation clips 101, 102respectively. Furthermore, as shown, the catheter device 502 furtherincludes: a tube 505 which includes an end 512 and the through-hole 510;an inner rod 530 that extends from the tube 505; and a ball 540detachably coupled to the inner rod 530. The end 512 of the tube 505 isopen to permit the first and second sutures 201, 202 to pass through theopened end 512 of the tube 505.

When the inner rod 530 is retracted to the tube 505 as shown in FIGS.6B-C, the ball 540 is constructed to snap onto a socket 542 and trap,and thus securing, the first and second sutures 201, 202 between theball 540 and socket 542 to form a ball-and-socket complex 550 and detachfrom the inner rod 530. The inner rod 530 is in an extended position atfirst and then the practitioner/physician can retract the inner rod 530back to the tube 505. The slidable blade 520 may be installed within thecatheter device 502 and positioned about the through-hole 510 with thepractitioner/physician controlling the slidable blade 520 of thecatheter device 502. As shown FIG. 6D, the slidable blade 520,controlled by a handle positioned outside of the patient, is then usedto cut the first and second sutures 201, 202 to release theball-and-socket complex 550. As shown in FIG. 6E, the ball-and-socketcomplex 550 holds the first and second sutures 201, 202 tightly againstthe first and second tissue approximation clips 101, 102, thus pullingon the two tissue approximation clips 101, 102 tightly towards eachother (i.e. the ball-and-socket complex 550 approximates the twoapproximation clips 101, 102). Therefore, the first and second tissueapproximation clips 101, 102 need not be magnetically attracted to eachother here, as the ball-and-socket complex 550 brings the first andsecond tissue approximation clips tightly to each other to form thetissue approximation clip complex 150.

Alternatively, as shown in FIGS. 7A-D, the clip approximating means maybe a suture adjoining clamp 601. The suture adjoining clamp 601 includesmovable arms 611, 612 as shown in FIG. 7A. Each of the arms 611, 612includes a grip 614 and a through-hole 616 through which threading ofthe first and second sutures 201, 202 are permitted. To thread thesutures 201, 202 through the suture adjoining clamp 601, a pre-loadedsuture threader 640 may be used as shown in FIG. 7E. The arms 611, 612of the suture adjoining clamp 601 are movable from a spaced-apartposition to an approximated position, and movable from the approximatedposition to the spaced-apart position. Furthermore, the suture adjoiningclamp 601 does not have to open wide. Additionally, the suture adjoiningclamp 601 may configured with a half-way lock or soft lock for the arms611, 612 so that the suture adjoining clamp 601 may be pushed down theinstrument channel 310 using a suture adjoining clamp applicator 410without getting caught somewhere while traveling through the instrumentchannel 310 towards the tissue defect 20. The suture adjoining clampapplicator 410 is similar to the applicator 400 described above. Asshown in FIGS. 7B-C, once at the tissue approximation complex 150, thesuture adjoining clamp 601 may be brought up against the tissueapproximation complex 150 and then clamped down. When, the first andsecond sutures 201, 202 are between the grips 614, and the arms 611, 612are in the approximated position, the grips 614 meet each other andfirmly hold down the first and second sutures 201, 202 as shown in FIG.7C. The grips 614 may be made from any material known in the art.Preferably, the grips 614 are made of soft material such as rubber.

As shown in FIGS. 7A-D, when the suture adjoining clamp 601 is used toapproximate the first and second tissue approximation clips 101, 102, acutting means for cutting the first and second sutures 201, 202 isdeployed. As shown in FIGS. 7A-C, the suture adjoining clamp applicator410 may further include the cutting means in the form of a slidablesheath 620 having a sharpened outer edge 622. A width of the slidablesheath 620 is greater than a width of the suture adjoining clamp 601.Accordingly, the outer edge 622 of the slidable sheath 620 is configuredto slide across the first and second sutures 201, 202 that are presentedby at least one of the through-holes 616 of the arms 611, 612 to cut thefirst and second sutures 201, 202.

Alternatively, as shown in FIG. 8, the cutting means may be a cuttingdevice 720 which includes a tube 722 having an end 724; a sidethrough-hole 726; and a cutting blade 728 that is constructed to slidedown to close the end 724 or slide up to open the end 724. The first andsecond sutures 201, 202 are threaded through the open end 724 and theside through-hole 726 when the blade 728 is pulled up; the threadingprocess may be aided by the pre-loaded suture threader 640 as shown inFIG. 7E. As shown in FIG. 8, the cutting device 720 is sized to passthrough the instrument channel 310 of the endoscope 300 with the end 724of the cutting device 720 being directed towards the tissue defect 20.Procedurally, when the suture adjoining clamp 601 is used, the device720 follows the suture adjoining clamp applicator 410 after the lattertransported the suture adjoining clamp 601 to the first and second clips101,102 to approximate the first and second clips 101, 102 into a tissueapproximation complex 150 and adjoin the suture adjoining clamp 601 tothe tissue approximation complex 150. The cutting blade 728 cuts thefirst and second sutures 201, 202 when the cutting blade 728, controlledby the practitioner/physician, slides down upon the first and secondsutures 201, 202 to close the end 724. Since the first and secondsutures 201, 202 can be brought together using the suture adjoiningclamp 601, there is no need to target the sutures 201, 202 individuallyat the GI lumen level as one would have to with other cutting devices.

The cutting device 720 shown in FIG. 8 may be adapted to be used withthe catheter device 501 similar to that shown in FIGS. 4E and 5 and thecatheter device 502 similar to that shown in FIGS. 6A-E. The catheterdevice 501, as shown in FIGS. 4E and 5, and the catheter device 502, asshown in FIGS. 6A-E, are disposed at distal end of their own applicator400, the distal end of the applicator 400 directed towards the tissuedefect 20. As shown, the catheter devices 501 and 502 include athrough-hole 510. The through-holes 510 of the catheter devices 501, 502permit the first and second sutures 201, 202 to pass therethrough.

When approaching the first and second tissue approximation clips 101,102, the catheter device similar to the catheter device 501 tensions thefirst and second sutures 201, 202 such that they are brought closertogether. By bringing the sutures 201, 202 closer together when thefirst and second sutures 201, 202 are tensioned and/or pulled, the firsttissue approximation clip 101 approaches the second tissue approximationclip 201 and both of the tissue approximation clips 101, 201(constructed here to magnetically attract each other) substantially andmagnetically couples to each other into a tissue approximation complex150 similar to the sequence depicted in FIG. 5 but without the depictedslidable blade 520. The cutting device 720 as shown in FIG. 8 may bethreaded with the first and second sutures 201, 202 and transportedthrough the instrument channel 310 of the endoscope 300 towards thetissue approximation complex 150. Without the need for thepractitioner/physician to grab the sutures 201, 202 and position themwithin the cutting devices known in the art at the level of the tissuedefect 20, which may prove to be challenging to thepractitioner/physician. Rather, the cutting device 720 is advantageousfor grabbing the sutures 201, 202 at the level of the port 330 of theinstrument channel 310 and allows capturing of both sutures 201, 202 atthe same time; the port 330, as shown in FIG. 8A, is disposed at orabout the proximal end of the instrument channel 310, whereas the distalend of the instrument channel 310 lies at or about the distal end ofinsertion tube 320.

The cutting device 720 shown in FIG. 8 may be adapted to be used withthe catheter device 502 similar to that shown in FIGS. 6A-E. Thecatheter device 502 here further includes a tube 505 which includes anend 512 and a through-hole 510; an inner rod 530 that extends from thetube 505; and a ball 540 detachably coupled to the inner rod 530. Theend 512 of the tube 505 is open to permit the first and second sutures201, 202 to pass through the opened end 512 of the tube 505. Thethrough-hole 510 of the catheter device 502 permits the first and secondsutures 201, 202 to pass therethrough. After the ball 540 substantiallyadjoins the first and second tissue approximation clips 101, 102 asshown in FIG. 6C, the inner rod 530 is detached from the ball 540. Thecatheter device 502 is then pulled back away from the tissue defect. Thecutting device 720, as shown in FIG. 8, may be threaded with the firstand second sutures 201, 202 and transported through the instrumentchannel 310 of the endoscope 300 towards the ball 540 substantiallyadjoined to the first and second tissue approximation clips 101, 102.Without the need to approach the tissue approximation complex 150, theoperator of the cutting device 720 may cut the first and second suturesat a distance from the tissue approximation complex 150 to release theball 540 and the first and second tissue approximation clips 101, 102 asa ball-and-socket complex 550 as shown in FIG. 6E.

FIGS. 4A-L illustrate a method for approximating a tissue defect 20using a gastrointestinal tissue approximation clip (“GI TAC”) system,the method including the steps of positioning a distal end of aninsertion tube 320 of an endoscope 300 towards a tissue defect inside ofa patient as shown in FIG. 4A; directing, via an applicator 400, a firsttissue approximation clip 101, detachably attached to the applicator400, through an instrument channel 310 of the endoscope 300 and towardsthe tissue defect 20 as shown in FIG. 4B; placing the first tissueapproximation clip 101 on a first location of the tissue defect 20 andclamping the first tissue approximation clip 101 thereon as shown inFIG. 4C; detaching the applicator 400 from the first tissueapproximation clip 101 and withdrawing the applicator 400 from theinstrument channel 310 of the endoscope 300 as shown in FIG. 4C;directing, via the applicator 400, a second tissue approximation clip102, detachably attached to the applicator 400, through the instrumentchannel 310 of the endoscope 300 and towards the tissue defect 20.

With regards to the second tissue approximation clip 102, the methodfurther includes: placing the second tissue approximation clip 102 on asecond location of the tissue defect 20 and clamping the second tissueapproximation clip 102 thereon; and detaching the applicator 400 fromthe second tissue approximation clip and withdrawing the applicator 400from the instrument channel 310 of the endoscope 300, the results ofwhich are shown in FIG. 4D. For this method, first and second sutures201, 202 are attached to the first and second tissue approximation clips101, 102 respectively as shown in FIGS. 3A-B and FIG. 4D.

Each of the first and second tissue approximation clips 101, 102includes: a body portion 110; and a grasping portion 120 coupled to thebody portion 110. The body portion 110 is detachably coupled to theapplicator 400. The grasping portion 120 is configured to grasp ontotissue during the placing steps. The grasping portion 120 includes amovable jaw that is constructed to move from a spaced-apart position toan approximated position, or move from the approximated position to thespaced-apart position. In the approximated position, the first andsecond jaw portions 1201, 1202 may be fully closed against each other orclosed upon a portion of a tissue of a patient. Other designs andconfigurations with respect to the jaw portions 1201, 1202 of thegrasping portion 120 may be considered that do not depart from thespirit and scope of the invention so long as the jaw is constructed toopen and close whereupon closure of the jaw onto tissue providessufficient clamping and hold onto the tissue.

Additional steps to the method include threading the first and secondsutures 201, 202, as shown in FIG. 4E, through a clip approximationmeans for approximating the first and second tissue approximation clips101, 102. Further, directing the clip approximating means towards thefirst and second tissue approximation clips 101, 102 such that the firsttissue approximation clip 101 moves towards the second tissueapproximation clip 102, the second tissue approximation clip 102 movestowards the first tissue approximation clip 101, or the first and secondapproximation clips 101, 102 move towards each other such that the firstand second tissue approximation clips 101, 102 approximates (withapproximation via magnetic attraction as an option) with each other toform a tissue approximation clip complex 150 as shown in FIGS. 4F-H; andcutting, using the clip approximation means or the cutting means, thefirst and second sutures 201, 202 from the first and second tissueapproximation clips 101, 102, wherein the first and second locations ofthe tissue defect 20 are approximated to each other following thedirecting step as shown in FIG. 4I. As shown, the clip approximationmeans is sized to travel through the instrument channel 310 of theendoscope 300.

In this method, the clip approximation means is a catheter device 501, acatheter device 502, or a suture adjoining clamp 601. Each of thecatheter devices 501, 502 include a slidable blade 520 and athrough-hole 510 which permits threading of the first and second sutures201, 202 therethrough as shown in FIG. 5 for the catheter device 501 andas shown in FIG. 6A-E for the catheter device 502. When the catheterdevice 501, or the catheter device 502, is used in the cutting step, theslidable blade 520 cuts the first and second sutures 201, 202 as shownin FIGS. 5 and 6D. The suture adjoining clamp 601, as shown in FIGS.7A-D, includes movable arms 611, 612 where each of the arms 611, 612 ofthe suture adjoining clamp 601 includes a grip 614 and a through-hole616 through which permits threading of the first and second sutures 201,202. As shown in FIG. 4D, suture adjoining clamp 601 is detachablycoupled to the applicator 410. Furthermore, the arms 611, 612 of thesuture adjoining clamp 601 are movable from a spaced-apart position toan approximated position, and movable from the approximated position tothe spaced-apart position. When the suture adjoining clamp 601 is usedin the cutting step, the suture adjoining clamp 601 may include acutting means in the form of a slidable sheath 620 having a sharpenededge 622 as described above. Alternatively, the cutting means is acutting device 720 as shown in FIG. 8, which includes a tube 722 havingan end 724, a side through-hole 726, and a cutting blade 728, followsthe suture adjoining clamp 601 after the suture adjoining clamp 601approximated the first and second tissue approximation clips 101, 102into a tissue approximation complex 150 and adjoined to the tissueapproximation complex 150. As shown in FIG. 8, the cutting device 720,having the first and second sutures 201, 202 threaded through the end724 and the side through-hole 726, is brought towards the sutureadjoining clamp 601 and the tissue approximation complex 150 to cut thefirst and second sutures 201, 202, as described above. Furthermore, thecutting device 720 may be adapted for use with the catheters 501, 502 asshown in FIGS. 5 and 6A and as described above.

With regards to the clip approximation means as the catheter device 502,as shown in FIG. 6, further includes the tube 505 which includes an end512 and a through-hole 510; an inner rod 530 that extends from the tube505; a ball 540 detachably coupled to the inner rod 530; and a slidableblade 520. The through-hole 510 permits threading of the first andsecond sutures 201, 202 therethrough. The end 512 of the tube 505 isopen to permit the first and second sutures 201, 202 to pass through theopened end 512 of the tube 505. The method using this catheter device501 may include an additional step of retracting, following thedirecting step and prior to the cutting step, the inner rod 530 of thecatheter device 502 into the tube 505 of the catheter device 502 suchthat the ball 540 of the catheter device 502 snaps onto the first andsecond sutures 201, 202 to form a ball-and-socket complex 550 that isreleased following the cutting step.

As shown in FIGS. 2B, 3A-B, 4A-L, 5, 6A-E, and 7A-D, the first andsecond tissue approximation clips 101, 102 adhere to each other viamagnetic force or other means (the ball-and-socket complex 550 shown inFIGS. 6A-E or the suture adjoining clamp 601 shown in FIGS. 7A-D) toform a tissue approximation clip complex 150 that further approximatesthe tissue defect 20; the tissue approximation complex 150 may beincluded in a ball-and-socket complex 550 as shown in FIG. 6E or beadjoined to a suture adjoining clamp 601 as shown in FIG. 6D. As shownin FIG. 4L, at least one tissue approximation clip complex 150 isclamped along the length of the defect. Following proper clamping of thetissue approximation clip complexes 150 along the length of the defect,the defect is finally closed by applying tissue closure clips 160 ataround the tissue approximation clip complex 150 of the semi-closeddefect after opposing sides of the defect are brought substantiallyclose together by at least one of the tissue approximation clipcomplexes 150 as shown. Alternatively, if the at least one tissueapproximation clip complex 150 sufficiently approximates the defect suchthat the defect resembles a substantially straight or a curved line savefor opposite ends of the line having a substantially small opening, thentissue closure clips 160 may be applied onto the substantially smallopening of the opposite ends of the line to close them.

To further control the first and second sutures 201, 202 that areattached to the first and second tissue approximation clips 101, 102respectively, the tissue approximation clip system 100 may furtherinclude a suture locking apparatus 800 as shown in FIGS. 9A-C. As shownin FIGS. 9B-C, the suture locking apparatus 800 includes an outer shell802 which includes a cavity 804, a through-hole 806, and an attachmentportion 808. The suture locking apparatus 800 may further include asuture guide 810 constructed to fit into the cavity 804 of the outershell 802 and first and second clamps 821, 822 to hold the first andsecond sutures 201, 202 respectively. For further adjustment of thesutures 201, 202, either the first and second clamps 821, 822 (or both)may be operated to release the hold that the clamps 821, 822 have on thesutures 201, 202. The attachment portion 808 of the outer shell 802 isconstructed to detachably attach the suture locking apparatus 800 ontothe instrument channel 310 of the endoscope 300. Procedurally, thesuture locking apparatus 800 is detachably coupled to a port 330 of theinstrument channel 310 of the endoscope 300 prior to transport of thefirst tissue approximation clip 101 as shown in FIG. 9A.

As shown in FIG. 9B, the suture guide 810 includes a through-hole 816wherein the first and second sutures 201 pass through the through-hole806 of the outer shell 802 and the through-hole 816 of the suture guide810. The suture guide 810 may be molded from any elastomer known in theart including, but not limited to, synthetic rubber, thermoplasticelastomers, and the like. Preferably, the suture guide 810 is moldedfrom synthetic rubber. Additionally, the method for approximatingclosure of a defect may further employ the use of the suture lockingapparatus 800 of FIGS. 9A-B to hold the first and second sutures 201,202.

In another embodiment, a gastrointestinal tissue approximation clip (“GITAC”) system is provided for approximating tissue defects 20, the GI TACsystem including: an applicator 400 that is sized to travel through aninstrument channel 310 of an endoscope 300; a plurality of tissueapproximation clips 100 that are transported to a plurality of locationsabout a tissue defect 20 by the applicator 400; a suture 200 coupled toat least one of the tissue approximation clips 100; and a clipapproximation means for approximating the tissue approximation clips100—the clip approximation means in this embodiment is similar to thoseembodiments previously described. Furthermore, the tissue approximationclips 100 are sized respectively to travel through the instrumentchannel 310, and the tissue approximation clips 100 are adapted to bedetachably coupled to the applicator 400.

As described in the earlier embodiments, each of the tissueapproximation clips 100 of this embodiment includes a body portion 110;and a grasping portion 120 that is coupled to the body portion 110. Thegrasping portion 120 includes first and second jaw portions 1201, 1202that are constructed to move from a spaced-apart position to anapproximated position, and move from the approximated position to thespaced-apart position. Furthermore, the grasping portion 120 isconstructed to grasp a portion of a tissue about the tissue defect 20,preferably about 5 mm to about 10 mm from an edge of the tissue defect20. The body portion 110 is constructed to be detachably coupled to theapplicator 400. Optionally, the tissue approximation clips 100 can beconstructed to magnetically attract each other. Also in this embodiment,the tissue approximation clips 100 further includes a pass-through hole141. This hole 141 is sized for the suture 200.

The first and second jaw portions 1201, 1202 of the grasping portion 120may be of a rat-toothed configuration as shown in FIGS. 2A-B anddescribed above. FIGS. 10A-C shows an alternative to the rat-toothedconfiguration, wherein an end of the first jaw portion 1201 includes aprotrusion 1211, and the second jaw portion 1202 includes a hole 1212,the hole 1212 constructed to accommodate the protrusion 1211 when thefirst jaw portion 1201 is closed with the second jaw portion 1202 asshown in FIG. 10C. The protrusion 1211 may be conical, pyramidal, orprismatic. Preferably, the protrusion 1211 is conical.

Alternatively, as shown in FIGS. 11A-C, the first and second jawportions 1201, 1202 may include a plurality of protrusions 1221, 1222that form concave portions 1223 of the first and second jaw portions1201, 1202 respectively. The protrusions 1221, 1222 shown in FIGS. 11A-Cresemble an array or row of teeth (or, an array or row of serrations) onthe first and second jaw portions 1201, 1202 respectively. As shown, theprotrusions 1221 of the first jaw portion 1201 are not aligned withrespect to the protrusions 1222 of the second jaw portion 1202 such thatthe protrusions 1221 of the first jaw portion 1201 fit in concaveportions 1223 of the second jaw portion 1202, and the protrusions 1222of the second jaw portion 1202 fit in the concave portions 1223 of thefirst jaw portion 1201—preferably in an interlocking manner when thefirst and second jaw portions 1201, 1202 are closed together. If theprotrusions 1221, 1222 were aligned with each other, then they would notinterlock with each other when the first and second jaw portions 1201,1202 are closed together. The size of the protrusions 1221, 1222 of thefirst and second jaw portions 1201, 1202 may be uniform. Alternatively,the size of the protrusions 1221, 1222 may increase (or decrease) from afirst end of the grasping portion 120 to the second end of the graspingportion 120, wherein the first end of the grasping portion 120 isdirected towards the body portion 110, and the second end of thegrasping portion 120 is directed away from the body portion 110.Alternatively, the size of the protrusions 1221, 1222 may be variablefrom the first end of the grasping portion 120 to the second end of thegrasping portion 120. Alternatively, there may be groups of two or moreprotrusions 1221, 1222 that increase (or decrease) in size from thefirst end of grasping portion 120 to the second end of the graspingportion 120.

As shown in FIGS. 12A-B, the tissue approximation clips 100 (those thatinclude a body portion 110 and a grasping portion 120 that is coupled tothe body portion 110) may further include a corkscrew element 1230 thatis configured to interact with the tissue. As shown in FIG. 12B, thefirst and second jaw portions 1201, 1202 are constructed to open up to180° from each other. Preferably, the first and second jaw portions1201, 1202 open to approximately 180° from each other so that thecorkscrew element 1230 can burrow itself (and penetrate) into the tissuebefore the first and second jaw portions 1201, 1202 can be brought backtogether and grasp a tissue portion that is situated about the tissuedefect 20. Furthermore, the tissue approximation clips 100 shown inFIGS. 12A-B may incorporate, in its grasping portion 120, therat-toothed configuration as shown in FIG. 2A, the protrusion 1211 andhole 1212 configuration as shown in FIGS. 10A-C, the plurality ofprotrusions 1221, 1222 configuration as shown in FIGS. 11A-C, or anyconfigurations for the grasping portion 120 that do not depart from thespirit and scope of this embodiment, or those that are known in the art.

As shown in FIG. 13A, the grasping portion 120 includes at least onepass-through hole 141. The first jaw portion 1201, the second jawportion 1202, or both of the first and second jaw portions 1201, 1202may include the pass-through hole 141 that is sized for the suture 200.Not only may the suture 200 traverse through the pass-through hole 141but also the suture 200 may be tied or coupled to the tissueapproximation clip 100 via the pass-through hole 141. For example, thesuture 200 may be tied to the tissue approximation clip 100 by using thepass-through hole 141 to tie the suture 200 to itself; alternatively,the suture 200 may be fused onto itself using the pass-through hole 141;alternatively, the suture 200 may be trapped between the body portion110 and the grasping portion 120; or otherwise fixed to the tissueapproximation clip 100. In this embodiment, the suture 200 is preferablycoupled to the first tissue approximation clip 101 (otherwise known asthe lead approximation clip) because the first tissue approximation clip101 is the first of the tissue approximation clips 100 to target thetissue defect 20 and grasp a tissue about the tissue defect 20.

Alternatively, as shown in FIG. 13B, the tissue approximation clips 100may include a suture attach ring 140 (“SAR”) that forms the pass-throughhole 141. Here, the ring 140 is disposed in the grasping portion 120that is approximate to the body portion 110, the pass-through hole 141being sized to permit the suture 200 to pass therethrough. The ring 140can be either round (“O” shaped) or any another shape that is suitablefor the purpose of attaching the suture 200 and/or permitting the suture200 to traverse the pass-through hole 141.

Alternatively, as shown in FIG. 13C, the ring 140 may be disposed on thebody portion 110 of the tissue approximation clip 100. As shown in FIG.13C, the ring 140 further includes a loop 142 that forms thepass-through hole 141. To fit the ring 140 on the body portion 110, thebody portion 110 further includes a surrounding groove 112 as shown inFIG. 13D (ring 140 omitted) that accepts a portion of the ring 140therein. The groove 112 is constructed to keep the ring 140 positionedabout the groove 112. Additionally, the ring 140 is configured to berotatable about the groove 112. For the tissue approximation clips 100shown in FIGS. 13A-B, the grasping portion 120 may be configured torotate about the body portion 110 to prevent suture 200 entanglement andpermit fine control of the tissue approximation clip 100. Thepractitioner may control this rotation using the applicator 400.

From the first tissue approximation clip 101, the suture 200 passesthrough the holes 141 of the other tissue approximation clips 100 suchthat the suture 200 brings the tissue approximation clips 100 togetherinto a multi-tissue approximation clip complex 155 (“Multi-TAC”) whenthe suture 200 is pulled as shown in FIGS. 14I-J, which in turnapproximates the tissue defect 20. The pass-through hole 141 allows thepractitioner to thread the suture 200 through it easily and the path ofthe suture 200 through the TAC's or Multi-TAC 155 can vary. The path ofthe suture 200 through the tissue approximation clips 100 placed aboutthe tissue defect 20 may be patterned in a manner that allowspurse-string cinching of the suture 200 as shown in FIG. 14F andapproximation of the tissue approximation clips 100 to form theMulti-TAC 155 as shown in FIGS. 14I-J, and thus, approximation of thetissue defect 20. Additionally, the path of the suture 200 may be afigure-eight, staggered, zig-zag, or the like.

To pull the suture 200 in a manner that approximates the tissueapproximation clips 100 together into a multi-TAC 155, a clipapproximation means may be deployed. As described in previousembodiments above, the clip approximation means may be either of thecatheter device 502 that forms the ball-and-socket complex 550 as shownin FIGS. 6A-E and 14J, or the suture adjoining clamp 601 (“SAC”) asshown in FIGS. 7A-E, 8, and 14I. The structure of the clip approximationmeans is the same here as described in previous embodiments. Followingthe approximation of the tissue approximation clips 100 and the tissuedefect 20, the practitioner cuts the suture 200 via the clipapproximation means. If the catheter device 502 is deployed as the clipapproximation means, then the catheter device 502 is used to approximatethe tissue approximation clips 100 (already clipped onto the tissueabout the tissue defect 20) when the catheter device 502 approaches andis close (or approximate) to the tissue approximation clips 100 and thesuture 200 is pulled, which is similar to that as shown in FIGS. 6B-C.As shown, the ball 540 is pulled towards the catheter device 502, snapsonto a socket 542 such that the suture 200 becomes trapped between theball 540 and the socket 542 to form a ball-and-socket complex 550 thataids in forming and maintaining the Multi-TAC 155 as shown in FIG. 14J.As similarly shown in FIGS. 6D-E, after the ball 540 is released, aslidable blade 520 of the catheter device 502 cuts the suture 200 torelease the ball-and-socket complex 550. If the SAC 601 is deployed asthe clip approximation means, the SAC 601 approximates the tissueapproximation clips 100 as the SAC 601 approaches and is close, orapproximate, to the tissue approximation clips 100 and the suture 200 ispulled in a similar manner as shown in FIG. 7A-E or 8. Following theapproximation of the tissue approximation clips 100 into the Multi-TAC155 and the approximation of the tissue defect 20, the arms 611, 612 ofthe SAC 601 approximate together which clamps the grips 614 together tosecure the suture 200 to the SAC 601. The suture 200 may be cut using acutting means, which can be either a slidable sheath 620 shown in FIG.7C or a cutting device 720 shown in FIG. 8 if the clip approximationmeans is the SAC 601 (the structure of these two different cutting meansis the same as described above). Additionally, the SAC 601 is thenreleased (or detached) from suture adjoining clamp applicator 410 assimilarly shown in FIG. 7D.

In another alternative embodiment, shown in FIGS. 14A-H, a method forapproximating a tissue defect 20 using a gastrointestinal tissueapproximation clip (“GI TAC”) system is provided, the method includingthe steps described below. A positioning step where the practitionerpositions a distal end of an insertion tube 320 of an endoscope 300towards a tissue defect 20 inside of a patient as shown in FIG. 14A. Adirecting step where the practitioner directs, via an applicator 400through an instrument channel 310 of the endoscope 300 and towards thetissue defect 20, a first tissue approximation clip 101 of a pluralityof tissue approximation clips 100, the first tissue approximation clip101 detachably attached to the applicator 400 and coupled to a suture200 as shown. A placing step where the practitioner places the firsttissue approximation clip 101 on a first location about the tissuedefect 20 and clamps the first tissue approximation clip 101 thereon. Adetaching step where the practitioner detaches the applicator 400 fromthe first tissue approximation clip 101 and withdraws the applicator 400from the instrument channel 310 of the endoscope 300. A threading stepwhere the practitioner threads the suture 200 through a pass-throughhole 141 of a second tissue approximation clip 102 of the plurality oftissue approximation clips 100 as shown in FIG. 14B—if the second tissueapproximation clip 102 comes pre-attached with a different suture 203,then the different suture 203 that is unneeded may be cut as shown andthe suture 200 can be threaded through the second tissue approximationclip 202 as shown. Another directing step, as shown in FIG. 14C, wherethe practitioner directs, via the applicator 400, the second tissueapproximation clip 102, detachably attached to the applicator 400,through the instrument channel 310 of the endoscope 300 and towards thetissue defect 20. Another placing step as shown in FIG. 14C, where thepractitioner places the second tissue approximation clip 102 on a secondlocation about the tissue defect 20 and clamps the second tissueapproximation clip 102 thereon. Another detaching step, as shown in FIG.14D, where the practitioner detaches the applicator 400 from the secondtissue approximation clip 102 and withdrawing the applicator 400 fromthe instrument channel 310 of the endoscope 300. The tissueapproximation clips 100 may still be constructed in this embodiment tobe magnetically attracted to each other as described in previousembodiments, which would provide an additional hold. However, themagnetic attraction configuration remains optional for this embodiment.

For the method in this embodiment, the tissue approximation clips 100include: a body portion 110; a grasping portion 120 coupled to the bodyportion 110; and the pass-through hole 141 that is sized for the suture200. The suture 200 is directly or indirectly coupled to the first andsecond tissue approximation clips 101, 102. It is preferable that thesuture 200 is tied or directly coupled to the first tissue approximationclip 101 since the first approximation clip 101 here serves as the leadtissue approximation clip. As shown in FIG. 14B, the suture 200 passesthrough the pass-through hole 141 of the second tissue approximationclip 102. As described in the earlier embodiments, the body portion 110is detachably coupled to the applicator 400 and the grasping portion 120includes first and second jaw portions 1201, 1202 that are constructedto move from a spaced-apart position to an approximated position, ormove from the approximated position to the spaced-apart position. Thegrasping portion 120 is configured to grasp onto tissue during theplacing steps. Specifically, the grasping portion 120 of the tissueapproximation clip 100 is constructed burrow into the tissue to allowthe first and second jaws 1201, 1202 of the grasping portion 120 tograsp the tissue and form a tissue mound as shown (the size of thetissue mound is illustrative for purposes of clarity, as the tissuemound is typically larger than what is shown due to the amount of tissuegrasped by the tissue approximation clips 100). The preferred locationof the tissue for the grasping portion 120 to grasp onto is about 5 mmto about 10 mm from an edge of the tissue defect 20.

As shown in FIGS. 14D-E, the method further includes additional placingand detaching steps, which repeats the placing and detaching stepsdescribed above using additional tissue approximation clips 103 from theplurality of tissue approximation clips 100 at additional locations ofthe tissue defect 20. As shown, the suture 200 travels from first tissueapproximation clip 101 to the second tissue approximation clip 102, andthen to the additional tissue approximation clips 103. A directing step,as shown in FIGS. 14F-H, where the practitioner directs a clipapproximating means (here, the SAC 601 as described earlier and shown inFIGS. 7A-B and 8) through the instrument channel 310 of the endoscope300 towards the tissue approximation clips 100 such the clipapproximating means aids in moving the tissue approximation clips 100towards each other such that the tissue approximation clips 100eventually approximate with each other and form a multi-TAC 155 in thesequence shown in FIGS. 14H-I from the suture 200 being sufficientlypulled via the clip approximating means, wherein the clip approximationmeans approaches and is close to, or abuts, the tissue approximationclips 100 and the suture 200 passes through the tissue approximationclips 102, 103 to be received by the clip approximating means as shown.Instead of the SAC 601, the clip approximating means may be the catheterdevice 502 that forms the ball-and-socket complex 550 as shown in FIG.14J and similarly shown in 6A-E. Optionally, the tissue approximationclips 100 may also be magnetically attracted to each other, as describedin earlier embodiments, to further aid in the formation of the multi-TAC155 with the clip approximating means as depicted in FIG. 5. Dependingon which clip approximation means is used, the practitioner may use aslidable blade 520 if the clip approximating means is the catheterdevice 520 or, if the clip approximating means is the SAC 601, a cuttingmeans (described above) to cut the suture 200 from the tissueapproximation clips 100 after the practitioner is satisfied that thetissue defect 20 is approximated by the Multi-TAC 155.

As shown in FIG. 14F, the path of the suture 200 through the first,second, and additional tissue approximation clips 101, 102, 103 mayencircle the tissue defect 20 such that when the suture 200 is retractedthrough the clip approximating means the tissue approximation clips 101,102, 103 may be drawn towards each other, like cinching a purse string,as the tissue defect 20 becomes smaller when the tissue defect 20 isbeing approximated as shown in FIG. 14H. Alternatively, the path of thesuture 200 may be a zig-zag as shown in FIG. 14G. Other paths that thepractitioner may employ for the suture 200 may include, but are notlimited to, figure-eight, staggered, and the like that do not departfrom the spirit and scope of the present embodiment.

Also shown in FIG. 14I, if the clip approximation means is the SAC 601,then the SAC 610 is constructed to clamp down onto the suture 200 viathe arms 611, 612 and grips 614 of the SAC 610 and the SAC 610 isdetached or decoupled from the SAC applicator 410 as described above. Asshown in FIG. 14J, if the clip approximation means is the catheterdevice 502, then the ball 540 is pulled to the catheter device 502 asdescribed similarly above, which causes the ball 540 to snap onto thesocket 542 such that the suture 200 becomes trapped between the ball 540and the socket 540 to form a ball-and-socket complex 550 that aids informing and maintaining the multi-TAC 155 as shown in FIG. 14J. Assimilarly shown in FIGS. 6D-E, after the ball 540 is released, aslidable blade 520 of the catheter device 502 cuts the suture 200 torelease the ball-and-socket complex 550. The simplicity and flexibilityof this method and the stability of the hold of the suture 200 providedby the clip approximation means result in the ability to approximate thetissue approximation clips 101, 102, 103 without requiring the tissueapproximation clips 101, 102, 103 to be magnetically attracted to eachother. The tissue approximation clips 101, 102, 103 may still beconstructed in this embodiment to be magnetically attracted to eachother as described in previous embodiments to provide an additional holdwith each other in the Multi-TAC 155, but the magnetic attractionconfiguration remains optional for this embodiment.

The construction of the tissue approximation clips 101, 102, 103 usedfor this method is similar to the constructions disclosed above inearlier embodiments. The first and second jaw portions 1201, 1202 of thegrasping portion 120 can be a rat-toothed configuration as shown in FIG.2A. Alternatively, an end of the first jaw portion 1201 includes aprotrusion 1211, and the second jaw portion 1202 includes a hole 1212 toaccommodate the protrusion 1211 when the first jaw portion 1201 in theapproximated position with the second jaw portion 1202 as shown in FIGS.10A-C. The protrusion 1211 may be conical, pyramidal, or prismatic.Preferably, the protrusion 1211 is conical. Alternatively, as shown inFIGS. 12A-B, each of the tissue approximation clips 100 further includesa corkscrew element 1230 that is configured to interact with the tissue(burrow and penetrate) provided that the first and second jaw portions1201, 1202 of the tissue approximation clips 100 are constructed toopen, up to about 180° from each other as shown in FIG. 12B.

Alternatively, as shown in FIGS. 11A-C, the first and second jawportions 1201, 1202 include a plurality of protrusions that form convexportions of the first and second jaw portions 1201, 1202 respectively.As shown, the protrusions 1221 of the first jaw portion 1201 are notaligned with respect to the protrusions 1222 of the second jaw portion1202 such that the protrusions 1221 of the first jaw portion 1201 fit inconcave portions 1223 of the second jaw portion 1202, and theprotrusions 1222 of the second jaw portion 1202 fit in the concaveportions 1223 of the first jaw portion 1201—preferably in aninterlocking manner when the first and second jaw portions 1201, 1202close together. If the protrusions 1221, 1222 were aligned with eachother than they would not interlock with each other when the first andsecond jaw portions 1201, 1202 are closed together. For the method, thegrasping portion 120 of the tissue approximation clips 100 that are used(first, second, and additional tissue approximation clips 101, 102, 103)may be the rat-toothed configuration as shown in FIG. 2A, the protrusion1212 and hole 1211 configuration as shown in FIGS. 10A-C, the pluralityof protrusions 1221, 1222 configuration as shown in FIGS. 11A-C, thecorkscrew element 1230 shown in FIGS. 12A-B, any configurations for thegrasping portion 120 that do not depart from the spirit and scope of thepresent embodiment, or any configurations that are known in the art.

Furthermore, the aforementioned different grasping configurations may becombined with each other. For example, the tissue approximation clips100 shown in FIGS. 12A-B, which further includes a corkscrew element1230 configured to interact with the tissue wherein the first and secondjaw portions 1201, 1202 of the tissue approximation clips 100 areconstructed to open up to about 180° from each other, may adopt any ofthe grasping configurations disclosed above to make the grasping abilityof the tissue approximation clip 100 more secure and strong. The tissueapproximation clip 100 that includes the corkscrew element 1230 mayadopt the grasping configuration shown in FIG. 2A wherein the first andsecond jaw portions 1201, 1202 of the grasping portion 120 can be arat-toothed configuration. Alternatively, the tissue approximation clip100 that includes the corkscrew element 1230 may adopt the graspingconfiguration shown in FIG. 10A-C wherein an end of the first jawportion 1201 includes a protrusion 1211, and the second jaw portion 1202includes a hole 1212 to accommodate the protrusion 1211 when the firstjaw portion 1201 in the approximated position with the second jawportion 1202. Alternatively, the tissue approximation clip 100 thatincludes the corkscrew element 1230 may adopt the grasping configurationshown in FIGS. 11A-C wherein the first and second jaw portions 1201,1202 include a plurality of protrusions that form convex portions of thefirst and second jaw portions 1201, 1202. Here, the configuration of theplurality of protrusions has been explained in detail above.

In this method, the grasping portion 120 for each tissue approximationclip 100 may include at least one pass-through hole 141 as shown in FIG.12A. Alternatively, as shown in FIG. 12B, each tissue approximation clip100 may further include a suture attach ring 140 (“SAR”) that forms thepass-through hole 141. The pass-through hole 141 is sized to permit thesuture 200 to pass therethrough. While the shape of the ring 140 may beround (“O” shaped), the shape of the ring 140 not limited to adopt thisshape in all embodiments. The ring 140 may adopt any other shape that issuitable for the purpose of attaching the suture 200 and/or permittingthe suture 200 to traverse through. For the tissue approximation clips100 shown in FIGS. 12A-B, the grasping portion 120 is constructed toswivel about the body portion 110. Alternatively, as shown in FIG. 12C,each tissue approximation clip 100 may include the ring 140, whichincludes a loop portion that forms the pass-through hole 141. Here, thebody portion 110 further includes a surrounding groove 112 that isadapted for the ring 140 to not only sit therein but also rotate aboutthe groove 112 to reduce entanglement of the suture 200 and permit finecontrol of the tissue approximation clip 100. The practitioner controlsthis rotation using the applicator 400.

For all of the embodiments that include the tissue closure clips 160,the tissue closure clips 160 are preferably made from materials which donot have affinity to magnets or have minimal interaction with magnets(e.g. non-ferromagnetic metals like titanium) so as not to interferewith any adjacent tissue approximation clip complex 150 and interferewith clamping process of the tissue approximation clip 100. As withother clips and suturing systems, new epithelium grown underneath thetissue approximation clips 100 will eventually push the tissueapproximation clips 100 off such that the tissue approximation clips 100slough off within a few weeks and then excreted through feces.

For all of the described embodiments, any metals used in theconstruction of either the tissue approximation clips 100 or the tissueclosure clips 160 should be made magnetic resonance imaging (MRI) safe(or at least MR conditional) as other clips in the market. Implantationof magnets in the body is generally thought not to be MRI safe. However,there are magnetic rings that may be placed laparoscopically at theesophagus/stomach junction that is considered to be “MR Conditional” forMRI systems up to 1.5 T. Approximately 89% of MRI machines in the U.S.are 1.5 T or lower, so the magnetic materials used to construct themagnetic rings may also be used for magnetic parts of the tissueapproximation clips 100 and tissue closure clips 160 (moreover for theformer) to ensure that they are MR Conditional for a large majority ofMRI systems in the U.S. Moreover, most clips should slough off within afew weeks. Additionally, simple X-rays may be ordered to see if theclips are still adhered to the GI wall. If the clips are still attachedand alternative diagnostic procedures cannot be used, then the tissueapproximation clips 100 and/or tissue closure clips 160 can be removedvia endoscopy or colonoscopy.

While the invention has been shown and described with reference todifferent embodiments thereof, it will be appreciated by those skilledin the art that variations in form, detail, compositions and operationmay be made without departing from the spirit and scope of the inventionas defined by the accompanying claims.

What is claimed is:
 1. A gastrointestinal tissue approximation clip (“GITAC”) system for approximating tissue defects, the GI TAC systemcomprising: an applicator that is sized to travel through an instrumentchannel of an endoscope; a plurality of tissue approximation clips thatare transported to a plurality of locations about a tissue defect by theapplicator; a suture coupled to at least one of the tissue approximationclips; and a clip approximation means for approximating the tissueapproximation clips, wherein the clip approximation means and the tissueapproximation clips are sized respectively to travel through theinstrument channel, and wherein the tissue approximation clips areadapted to be detachably coupled to the applicator.
 2. The GI TAC systemof claim 1, wherein each of the tissue approximation clips comprises: abody portion; and a grasping portion that is coupled to the bodyportion; and a pass-through hole, wherein the grasping portion includesfirst and second jaw portions that are constructed to move from aspaced-apart position to an approximated position, and move from theapproximated position to the spaced-apart position, wherein the graspingportion is constructed to grasp a portion of a tissue about the tissuedefect, and wherein the body portion is constructed to be detachablycoupled to the applicator.
 3. The GI TAC system of claim 2, wherein thefirst and second jaw portions of the grasping portion is of arat-toothed configuration, or wherein an end of the first jaw portionincludes a protrusion, and the second jaw portion includes a hole toaccommodate the protrusion when the first jaw portion in theapproximated position with the second jaw portion.
 4. The GI TAC systemof claim 2, wherein the first and second jaw portions include aplurality of protrusions, wherein the protrusions of the first jawportion are not aligned with respect to the protrusions of the secondjaw portion, and wherein the protrusions of the first jaw portioninterlock with the protrusions of the second jaw portion when the firstand second jaw portions are closed together.
 5. The GI TAC system ofclaim 2, wherein each of the tissue approximation clips furthercomprises a corkscrew element that is configured to interact with thetissue, and wherein the first and second jaw portions of the tissueapproximation clips are constructed to open, up to 180° from each other.6. The GI TAC system of claim 2, wherein each of the tissueapproximation clips further comprises a ring that forms the pass-throughhole.
 7. The GI TAC system of claim 6, wherein the ring includes a loopportion that forms the pass-through hole, wherein the body portionincludes the ring and a surrounding groove that accepts a portion of thering therein, wherein the groove is constructed to keep the ringpositioned about the groove, wherein the ring is rotatable about thegroove, and wherein the suture passes through the holes of the tissueapproximation clips such that the suture approximates the tissueapproximation clips together, when the suture is pulled, and the tissuedefect is approximated.
 8. The GI TAC system of claim 2, wherein thegrasping portion includes at least one of the pass-through hole.
 9. TheGI TAC system of claim 1, wherein the clip approximation means is acatheter device, the catheter device comprising: a tube which includesan end and a through-hole; an inner rod that extends from the tube; aball detachably coupled to the inner rod; a socket detachably coupled tothe tube; and a slidable blade to cut the suture, wherein the end of thetube is open to permit the suture to pass through the opened end of thetube, and wherein, when the inner rod is retracted into the tube, theball is constructed to snap onto the socket to trap the suture betweenthe ball and the socket, and the ball detaches from the inner rod andthe socket detaches from the tube to form a ball-and-socket complex toapproximate the tissue approximation clips.
 10. The GI TAC system ofclaim 1, wherein the clip approximation means is a suture adjoiningclamp, the suture adjoining clamp comprising movable arms, wherein eachof the arms of the suture adjoining clamp includes a grip and athrough-hole through which threading of the suture is permitted, andwherein the arms of the suture adjoining clamp are movable from aspaced-apart position to an approximated position, and movable from theapproximated position to the spaced-apart position.
 11. The GI TACsystem of claim 10, further comprising a suture adjoining clampapplicator that transports the suture adjoining clamp through theinstrument channel, wherein the suture adjoining clamp applicatorincludes a slidable sheath having a sharpened outer edge, wherein awidth of the slidable sheath is greater than a width of the sutureadjoining clamp, and wherein the outer edge of the slidable sheath isconfigured to slide across the suture, that is presented by at least oneof the through-holes of the arms, to cut the suture.
 12. The GI TACsystem of claim 10, further comprising a cutting device which includes:a tube having an end; and a blade to cut the suture, wherein the cuttingdevice is sized to pass through the instrument channel of the endoscope,wherein the blade is constructed to slide away from about an edge of thetube end to open the end of the tube, wherein the blade is constructedto slide towards to at least about the edge of the tube end to cut thesuture, and wherein the end, when opened, creates a through-hole thatpermits the suture to pass through.
 13. A method for approximating atissue defect using a gastrointestinal tissue approximation clip (“GITAC”) system, the method comprising the steps of: positioning a distalend of an insertion tube of an endoscope towards a tissue defect insideof a patient; directing, via an applicator through an instrument channelof the endoscope and towards the tissue defect, a first tissueapproximation clip of a plurality of tissue approximation clips, thefirst tissue approximation clip detachably attached to the applicatorand coupled to a suture; placing the first tissue approximation clip ona first location about the tissue defect and clamping the first tissueapproximation clip thereon; detaching the applicator from the firsttissue approximation clip and withdrawing the applicator from theinstrument channel of the endoscope; threading the suture through apass-through hole of a second tissue approximation clip of the pluralityof tissue approximation clips; directing, via the applicator, the secondtissue approximation clip, detachably attached to the applicator,through the instrument channel of the endoscope and towards the tissuedefect; placing the second tissue approximation clip on a secondlocation about the tissue defect and clamping the second tissueapproximation clip thereon; and detaching the applicator from the secondtissue approximation clip and withdrawing the applicator from theinstrument channel of the endoscope.
 14. The method of claim 13, whereineach of the tissue approximation clips includes: a body portion; agrasping portion coupled to the body portion; and the pass-through holethat is sized for the suture, wherein the body portion is detachablycoupled to the applicator, wherein the grasping portion includes firstand second jaw portions that are constructed to move from a spaced-apartposition to an approximated position, or move from the approximatedposition to the spaced-apart position, and wherein the grasping portionis configured to grasp onto tissue during the placing steps.
 15. Themethod of claim 14, wherein the first and second jaw portions of thegrasping portion is a rat-toothed configuration, wherein an end of thefirst jaw portion includes a protrusion, and the second jaw portionincludes a hole to accommodate the protrusion when the first jaw portionin the approximated position with the second jaw portion, or whereineach of the tissue approximation clips further comprises a corkscrewelement that is configured to interact with the tissue such that thefirst second jaw portions of the tissue approximation clips areconstructed to open, up to about 180° from each other.
 16. The method ofclaim 14, wherein the first and second jaw portions include a pluralityof protrusions, wherein the protrusions of the first jaw portion are notaligned with respect to the protrusions of the second jaw portion, andwherein the protrusions of the first jaw portion interlock with theprotrusions of second jaw portion when the first and second jaw portionsare closed together.
 17. The method of claim 14, wherein each of thetissue approximation clips further comprises a ring that forms thepass-through hole.
 18. The method of claim 13, further comprising thesteps of: repeating the placing and detaching steps using additionaltissue approximation clips from the plurality of tissue approximationclips at additional locations about the tissue defect wherein the suturetravels from first tissue approximation clip to the second tissueapproximation clip, and then to the additional tissue approximationclips; directing a clip approximating means towards the tissueapproximation clips such that the tissue approximation clips movetowards each other to approximate with each other and form amulti-tissue approximation clip complex; and cutting, using the clipapproximation means or a cutting means, the suture from the tissueapproximation clips, wherein the first, second, and additional locationsabout the tissue defect are approximated to each other following thedirecting step, and wherein the clip approximation means and the cuttingmeans are sized to travel through the instrument channel of theendoscope.
 19. The method of claim 18, wherein the clip approximationmeans is a catheter device or a suture adjoining clamp, wherein thecatheter device includes a slidable blade and a through-hole whichpermits threading of the suture therethrough, wherein the sutureadjoining clamp includes movable arms wherein each of the arms of thesuture adjoining clamp includes a grip and a through-hole through whichpermits threading of the suture, wherein the arms of the sutureadjoining clamp are movable from a spaced-apart position to anapproximated position, and movable from the approximated position to thespaced-apart position, wherein the suture adjoining clamp is detachablycoupled to the applicator, wherein, when the catheter device is used inthe cutting step, the slidable blade of the catheter device cuts thesuture, and wherein, when the suture adjoining clamp is used in thecutting step, the cutting means for cutting the suture is deployed. 20.The method of claim 19, further comprising the step of: retracting,following the directing step and prior to the cutting step, an inner rodof the catheter device into a tube of the catheter device such that aball of the catheter device snaps onto a socket of the catheter deviceto trap the suture between the ball and the socket to form aball-and-socket complex, wherein the catheter device further includes:the tube which includes an end and the through-hole; the inner rod thatextends from the tube; the socket detachably coupled to the tube; andthe ball detachably coupled to the inner rod, wherein the end of thetube is open to permit the suture to pass through, and wherein a path ofthe suture from the first tissue approximation clip to the second tissueapproximation clip and then to the additional approximation clips issubstantially a loop, a figure-8, or a zig-zag.